The STET Quality & Process Engineer is responsible for verification / validation via the APQP-PSW process on supplier related projects. They ensure compliance to regulatory requirements and/or procedures for regulated products/processes. They will also mine CoNQ data (QN, Warranty, Scrap, Obso) to identify opportunities for improvements and then execute on those opportunities. **​What you will do in this role** : + Lead technical capability assessment, technology reviews and sourcing board files. + Lead LRP and APQP Level 4, Process Validation. Drive APQP plan development, execution, monitoring and control + Strong Understanding in Cp, Cpk and MSA. + Deeper understanding of design within individual technical field- Plastics, PCBA, etc to drive DFMAT at suppliers. + Lead and challenge Critical to Quality characteristics flow down to Suppliers and communicate feedback to R&D. + Lead Analysis of defects for deciding if supplier caused and then notified for NCRs and IIA. + Lead problem solving for SQNs, SCAR and Quality Improvement plan. + Lead, own SICRs at site levels, and manage SICRs priorities with stakeholders. + SME, can be a trainer. Able to demonstrate and solve complex problems using problem solving tools. Strong control over DFMEA to PFMEA linkage and process controls. + Lead Supplier improvement and communicate the challenges and resolutions to stakeholders. + Lead factory support per site for supplier related issues. **KEY PERFORMANCE INDICATORS** + Supplier Product Quality targets met at launch – NPI (PDLM)/MLD projects. + Meet the requirement for Process Validation and PSW Deliverables on time to target milestones. + Execute SICRs in timely manner to avoid any operational line down. **REQUIRED COMPETENCIES** + Stakeholder Management + Effective Communication + Collaboration/Teamwork + Conflict resolution and negotiation + Hands on Design and technical experience. + Project Management + Process Validation and Verification + ISO 13485/9001 and FDA requirements, IEC 60601-1 + Problem Solving skills through 6 sigma/Leon/Other strategic approach. + Knowledge of Statistical methods and analysis. Experience with Quality tools (MSA, Process Capability and SPC). **Education & Training –** + Bachelor’s or Master’s degree in Engineering’ (Mechanical/ Electronics/ Electrical) **Experience & Background** + Minimum of 8 years of related engineering experience (medical device or regulated industry preferred). + Wide-ranging experience within an engineering function. + Well versed in Quality Engineering and Continuous Improvement techniques. + Direct working relationships with suppliers + Participated in several NPIs from start to finish. + Direct shop-floor production engineering sustaining experience + Six Sigma (DMAIC) Statistical methods and analysis experience. Experience with Quality tools (MSA, Process Capability and SPC) + Experience in QMS- ISO 13485/9001 and FDA requirements, IEC 60601-1